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華潤雙鶴(600062.SH):注射用帕瑞昔布鈉獲批上市
格隆匯 06-04 16:52

格隆匯6月4日丨華潤雙鶴(600062.SH)宣佈,近日,公司收到了國家藥監局頒發的注射用帕瑞昔布鈉《藥品註冊證書》(證書編號:2021S00561),批准該藥品生產。該藥品用於手術後疼痛的短期治療。

華潤雙鶴於2019年9月29日向國家藥監局提交該藥品的上市申請,於2019年11月8日獲得受理通知書,並於2021年6月1日獲得國家藥監局批准。根據國家相關政策規定,該次獲得《藥品註冊證書》視同通過一致性評價。

截至該公吿日,華潤雙鶴針對該藥品累計研發投入為人民幣2670.56萬元(未經審計)。

原研注射用帕瑞昔布鈉由輝瑞製藥和法瑪西亞聯合開發,2002年3月首次在歐洲上市,商品名為“Dynastat”,2008年5月獲准在中國上市,商品名為“特耐”。迄今為止,該藥已在歐盟、中國等十幾個國家上市銷售。根據全球71國家藥品銷售數據庫顯示,2020年,注射用帕瑞昔布鈉全球銷售額為2.69億美元。其中,“Dynastat”全球銷售額為1.21億美元。

國內市場,根據米內網藥品招投標信息顯示,中國大陸境內已批准上市的注射用帕瑞昔布鈉生產企業25家。根據米內網數據顯示,2020年注射用帕瑞昔布鈉銷售總額(終端價)為21.96億元,其中企業排名前五分別是:輝瑞43.18%,湖南科倫製藥26.05%,齊魯製藥12.09%,正大天晴11.06%,江蘇奧賽康藥業3.98%。

該藥品獲得《藥品註冊證書》,進一步豐富了公司產品線,有助於提升公司產品的市場競爭力。

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